AMERICAN ORTHOPAEDIC SOCIETY FOR SPORTS MEDICINE OSTEOARTHRITIS BASIC SCIENCE RESEARCH GRANT

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1 AMERICAN ORTHOPAEDIC SOCIETY FOR SPORTS MEDICINE OSTEOARTHRITIS BASIC SCIENCE RESEARCH GRANT GENERAL INFORMATION The purpose of these grants is to foster high-quality research in the areas of early osteoarthritis and prevention of OA progression. A list of research priorities identified by leaders in the field is below but applicants need not limit studies to only these issues. Proposed studies need not relate specifically to sports injuries. Projects involving viscosupplementation will not be considered for either grant. Applications will be reviewed for their potential impact on the field, the quality of study approach, and ability of investigator and site(s) to conduct and complete the proposed research. Research Priorities: 1) Current knowledge of early disease development is limited. Additional mechanistic studies are needed to characterize early events in osteoarthritis and how these might be affected by joint injury. 2) An increased understanding of disease initiation and the factors that drive disease could improve therapy development and selection. Identification of events that initiate and propagate disease is needed to achieve this goal. 3) Identification of specific acute injury mechanisms that may contribute to increased likelihood of disease progression, providing potential interventional targets. 4) Determination and optimization of treatment time courses to determine the validity of a mono or multi-therapeutic approach. Also it would be beneficial to determine the preferred time for intervention and identify therapeutic agents/procedures optimized for each phase and stage of injury or disease. 5) Continue to evaluate epigenetics and its potential to delay degenerative disease post-injury through modulation of gene expression. Continue to explore the potential for epigenetic based treatments. 6) Evaluate new potential chondroprotective agents, with a focus on agents/drugs that have prior FDA approval or could get fast approval. FUNDING: This program provides a one-time award of $50,000 to support a lab/basic science project. Any investigative team seeking such a grant must include at least one member of AOSSM in good standing. No AOSSM Board officer (e.g., President, Vice President, Treasurer, etc.) may be a named investigator on any application. GUIDELINES TO COMPLETE THE APPLICATION: I. APPLICATION REQUIREMENTS A. The grant application must be completed in full and submitted together with the supporting data requested in the application form. Any application not completed in full will not be considered. B. The completed application must be accompanied by an up to date biographical sketch of the principal investigator, as well as a brief biographical sketch for all co-investigators. Limit publications to most recent publications or those most pertinent to the investigation being proposed. II. APPLICATION PROCEDURES Download the Cover Sheet from the AOSSM website. Complete the form and other elements offline and combine into one Portable Document File (PDF). Note: In order to combine the Cover Sheet with other elements, you will probably need to save it as a flat (non-interactive) PDF. One way to do this is to click on the Print icon and select Adobe PDF as the printer. You will then be prompted for the location to save the file. You should then be able to combine it with the other files. Some type of PDF-creation software such as Adobe Acrobat is necessary to create the PDF from

2 Word or other word processing programs. (The free Adobe Reader will not create a PDF.) You can download a trial version of Acrobat from the Adobe website. Additionally, applicants may find Planet PDF s Find PDF Software feature ( useful to browse or search a comprehensive database of free, shareware, or commercial PDF products. Applicants should choose the PDF-creation software that best suits their needs. It is recommended that, as much as possible, applicants avoid scanning text documents to produce the required PDFs. Instead, we recommend producing the documents electronically using text or word-processing software and then converting documents to PDF. DISCLAIMER: References to software packages or Internet services neither constitute nor should be inferred to be an endorsement or recommendation of any product, service, or enterprise by AOSSM. No warranties are stated or implied. Once you have created the PDF, the application as an attachment to Kevin M. Boyer, MPH ([email protected]), Director of Research for AOSSM. III. IV. DEADLINE FOR FINAL APPLICATION You must complete your submission no later than 11:59pm Central, January 1 to be considered for this program. MODIFICATIONS Grantee(s) must receive written permission from AOSSM prior to moving funds between budget categories, changing effective dates of the grant, or making any other desired modifications. Grantee(s) may terminate a grant prior to normal expiration by notifying the AOSSM office in writing and stating the reasons for termination. Unexpended funds must be returned to AOSSM within sixty (60) days, together with a final accounting of expenditures under the grant. AOSSM reserves the right to terminate the grant at any time upon three months written notice to the grantee(s). V. FISCAL PROCEDURES AND POLICIES A. Facilities to be provided by the grantee(s) or their parent institutions. Research grants are designed to serve as supplementary funding for meritorious projects initiated or contemplated by the grantee(s) and their parent institutions. Therefore, the grantee(s) and such institutions are expected to provide all the necessary basic facilities and services normally expected in professional environments qualified to undertake research related to sports medicine. In particular, AOSSM expects that the grantee(s) will have available, whether from their own resources, funds other than those assigned by AOSSM, or from their parent institutions the following, unless otherwise specifically agreed upon: 1. Laboratory space; 2. Maintenance services, including maintenance supplies and service contracts; 3. Telephone service, if needed; 4. Library services, including subscriptions to periodicals and the purchase of books; 5. Laboratory furniture; 6. Salaries of principal investigator or other project personnel, unless otherwise agreed upon; 7. Foreign and local travel expenses of personnel working under the AOSSM grant; 8. Society dues and memberships of personnel working under the AOSSM grant; 9. Workers' compensation, public liability or other hazard and special insurance; 10. Office equipment; 11. Employee group life, disability, medical expense or hospitalization insurance; 12. Audio/visual project support devices and items; and

3 13. Hospital bed expense, nursing or related services, even when used for research studies pertinent to the subject of the AOSSM research grant. As a matter of policy, AOSSM grant funds may not be spent for remodeling or building construction costs or travel expense. AOSSM funds under the grant may not be used to pay institutional overhead/indirect (facilities and administrative) expenses. Since funds are relatively small, the bulk of the grant should generally be dedicated to purchasing those materials that are directly related to completion of the project. The cost of animals and animal care, cadavers, disposable or non-reusable experimental equipment or costs for use of equipment in the institution are generally justified. The purpose of this grant is not to stock laboratory with relatively permanent equipment or to pay an outside institution to perform work of the experiment. For example, paying for interpretation of x-rays or histological sections by an outside institution would usually not be considered acceptable. B. Budgets Applicants are free to present their proposed budget in any format. Please list each major expense separately with a brief description and total amount. Supplies under $1000 do not need to be itemized. If animals are to be purchased, state the species and the number to be used. C. Expenditure Report for Those Receiving Grants At the end of the funded study, the grantee(s) must prepare, sign (together with the countersignature of the responsible financial official of the parent institution where appropriate), and submit to the AOSSM office a report of grant expenditures. A final narrative report is also required at the completion of the study that summarizes research findings. D. Financial Records Separate accounts must be maintained for each grant. These accounts, with substantiating invoices and other expenditure data, must be available at all times to representatives of AOSSM. E. Unexpended Balances -- Completed Grants Any unexpended balances of $100 or more at the scheduled conclusion, or other termination of any AOSSM grant must be refunded to AOSSM within sixty (60) days or by July 31 of the year the grant is ended, together with the final report of the grant fund expenditures. VI. OTHER INSTRUCTIONS BIOGRAPHICAL SKETCH Download the NIH Biographical Sketch form ( R_biosketch_VerB.doc) With your application, please include the biographical sketches of all KEY personnel including consultants. Use the sample format on the Biographical Sketch with Sample ( to prepare this section. Note: The Biographical Sketch may not exceed four pages. Items A and B (together) may not exceed two of the four-page limit. Complete the educational block at the top of the format page, and complete sections A, B, C, and D as described below. You do not need to fill in the era COMMONS USER NAME box.

4 A. Personal Statement. Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. Within this section you may, if you choose, briefly describe factors such as family care responsibilities, illness, disability, and active duty military service that may have affected your scientific advancement or productivity. B. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee. C. Selected Peer-reviewed Publications. AOSSM encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. Citations that are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material). D. Research Support. List both selected ongoing and completed (during the last three years) research projects (Federal or non-federal support). Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the senior/key person identified on the Biographical Sketch. Do not include number of person months or direct costs. Don t confuse Research Support with Other Support. Though they sound similar, these parts of the application are very different. As part of the biosketch section of the application, Research Support highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. In contrast, Other Support information is required for all applications that are selected to receive grant awards. AOSSM staff will request complete and up-to-date other support information from you after peer review. This information will be used to check that the proposed research has not already been Federally-funded. SPECIFIC AIMS List the broad, long-term objectives and what the specific research proposed in this application is intended to accomplish, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, or develop new technology. Specific Aims are limited to one page. RESEARCH PLAN The Research Plan should include sufficient information needed for evaluation of the project, independent of any other document. Be specific and informative, and avoid redundancies. The Research Plan has a limit of five pages. Organize the Research Plan to answer these questions: 1. What do you intend to do? 2. Why is the work important? 3. What has already been done? 4. How are you going to do the work? RESEARCH PLAN FORMAT Organize the Research Plan in the specified order and using the instructions provided below. Start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the References Cited section.

5 Significance Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. Innovation Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. Approach Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. If an applicant has multiple specific aims, then the applicant may address significance, innovation and approach for each specific aim individually, or may address significance, innovation and approach for all of the specific aims collectively. As applicable, also include the following information as part of the research strategy, keeping within the three sections listed above: Significance, Innovation, and Approach. REFERENCES CITED List all references. The list may include, but may not replace, the list of publications required in the Progress Report for competing continuation applications. Each reference must include the title, names of all authors, book or journal, volume number, page numbers, and year of publication. The reference should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research. APPENDIX Applications may include the following materials in the appendix: Surveys, questionnaires, data collection instruments, and clinical protocols. Cover letter (optional) Letters of support (optional)

6 IX. PUBLICATION AOSSM s first right of publication of grantee(s) research findings resulting from AOSSM grants are reserved for consideration of publication by the Editorial Board of The American Journal of Sports Medicine. AOSSM should be sent reprints of all papers and publications resulting from work done under an AOSSM grant, including those that appear after the grant has been terminated. The following acknowledgment must appear as a footnote on the first page of the manuscript or printed text: SUPPORTED BY A GRANT FROM THE AMERICAN ORTHOPAEDIC SOCIETY FOR SPORTS MEDICINE. The same credit line must be included when the grantee(s) presents a paper at a professional or scientific meeting based on a study funded by AOSSM. X. INVENTIONS OR FINANCIAL GAIN The American Orthopaedic Society for Sports Medicine (AOSSM) reserves the right to be reimbursed for the amount of the grant if any financial gain is realized as a result of the development of a commercial product that occurs during the research process under an AOSSM grant. Any patents generated by the funded research cannot become property of any of the investigative team. Assignments of such rights would be made by the AOSSM. XI. XII. OWNERSHIP OF EQUIPMENT Equipment purchased under AOSSM grants becomes the property of the parent institution of the grantee(s) or its associated facilities. CORRESPONDENCE Any questions or requests should be directed to Kevin M. Boyer, MPH, Director of Research for the American Orthopaedic Society for Sports Medicine ([email protected]; ). ADDITIONAL GUIDELINES FOR A SUCCESSFUL GRANT 1) The proposed grant may use methods and/or apparatus previously proven by one of the co-investigators. However, the grant should not simply be a clear extension of work previously done or continuation of work currently being done by one of the co-investigators. 2) A grant will have more support if a pilot project and/or a sample size estimate are done first. This does not have to be extensive or include large number of experiments. However, a pilot project will often demonstrate that the principal investigator has thought through the project from beginning to end, and that there is reasonable expectation that the project will result in tangible results. When possible, simple power calculations should be made using the results of the pilot study to justify the number of experiments requested in the budget. This will also give the reviewers some assurance that a statistically significant result might be detected. 3) The results of any pilot project should be used in the budget justification. 4) Due to the relatively limited nature of the grant, the methods to be used in the grant should be clearly established as valid or easily tested. A pilot project is usually necessary to prove that the experimental technique is workable. If a pilot project is not done in advance, one should be sure to explain how previously used techniques should be applicable to the project being proposed.